FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68788-8299
11-digit product format
687888299
Labeler code
68788
Product ID
68788-8299_7ee9ba8c-2b3f-451a-b699-4ec1e1813bde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065373
Marketing category
ANDA
Marketing start
2022-11-29
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617993

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8299-1Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLESUSPENSION1255
68788-8299-7Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLESUSPENSION755

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8299-1ML - Milliliter68788-8299f2f3ca63-6c2d-46b2-9be6-c9b8312bcc6e12023-01-09
68788-8299-7ML - Milliliter68788-8299905d9581-1a18-4248-859c-4d682aacdcd312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8299AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240214_fc31a5df-aa1c-4b0f-8c64-a14236df4a02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYfc31a5df-aa1c-4b0f-8c64-a14236df4a025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8299-168788829901125 mL in 1 BOTTLE (68788-8299-1) 125 ml2022-11-290000-00-00NoNoCurrent
68788-8299-76878882990775 mL in 1 BOTTLE (68788-8299-7) 75 ml2022-11-290000-00-00NoNoCurrent